Breast implant capsular contracture remains a significant complication of cosmetic and reconstructive breast surgery. The economic impact of capsular contracture is significant. Rates for both saline and silicone gel implants are 10% for primary cosmetic augmentations and 15 to 30% for reconstruction. There were 347,524 breast augmentations and 43,091 breast reconstructions in the United States in 2007. Therefore, this year alone approximately 47,679 new cases of capsular contracture will be diagnosed. Capsular contracture may also form in the advent of buttocks augmentation surgery and calf augmentation.
Following surgery, capsules form as a normal response around a foreign body (eg. breast implants, pacemakers, orthopedic joint prosthetics). Histologically, the human breast capsular tissue is comprised of an inner layer of fibrocytes and histiocytes, which are surrounded by a thicker layer of collagen bundles arranged in a parallel array. Capsular contracture is an abnormal response of the human immune system to foreign material. In capsular contracture, there is an overgrowth of scar tissue resulting in tightening of the implant. Capsular contracture may become painful and cause distortion of and hardness over the implant
The potential etiologies include the hypertrophic scar hypothesis, myofibroblasts, silicone gel bleed, hematoma and infectious theory. Most experts feel that capsular contracture is a multifactoral problem. The best preventative measure is a sound surgical technique. The techniques described below lower the rate of capsular contracture, but do not completely eliminate its formation.
Present preventative measures against capsular contracture are refined surgical techniques including breast pocket irrigations before placement of the implants. Such procedures may include a betadine alternative including a combination of 50 ml of stock betadine solution, 1 g of cefazolin, 80 mg gentamycin and 500 ml normal saline. Although used by many surgeons, betadine irrigation is only recommended by the FDA due to concerns of the silicone shell viability. A nonbetadine alternative involves a triple antibiotic solution combination comprising 50,000 units of bacitracin, 1 g cefazolin, 80 mg gentamicin and 500 ml normal saline.
Other surgical techniques to prevent capsular contracture include atraumatic pocket dissection under direct vision, avoiding blunt instrumentation, irrigation of the pocket with 120 to 150 ml of irrigation without active evacuation, cleansing of skin surrounding incisions with irrigation solution, surgical glove change before implant handling, aseptic implant insertion and minimized implant manipulation after insertion.
Perioperatively, systemic antibiotics, textured implants, glove change before implant handling, aseptic implant insertion and use of post operative drains have been recommended in the prevention of capsular contracture.
Post-operative treatment of capsular contracture includes: Non-surgical treatment (conservative) of capsular contracture such as: administration of high doses of ibuprofen (Advil®), naproxen sodium (Aleve®) or other nonsteroidal anti-inflammatory medications; massage, Vitamin E, Off label use of Montelukast sodium (Singulair®) or Zafirlukast (Accolate®), or any combinations of the above. All the above conservative measures have been limited in the number of patients improved with their usage as well as in the scope of the improvement.
Examples of surgical treatment of capsular contracture are surgical dissection of the capsule comprising total capsulectomy (removal) or capsulotomy (release) and change in implant anatomical location (i.e., from subglandular to subpectoral). Recurrence rates following surgical treatment are as high as 50%.
United States Patent Publication No. 20070196454 by Stockman, et al., describes a method where applying cross linked gels comprising polyalkyleneimines to the area between the implant and body tissue to be used as a coating for the breast implant in order to retard or reduce the extent of fibrosis. However, this process involves internal application which may lead to further complications and thus is not a long-lasting solution.
In view of the above difficulties with available procedures, there still exists a need for a simple, noninvasive method for the prevention and treatment of capsular contracture and other fibrosis related conditions.